Trial Outcomes & Findings for Two Approaches to Routine HIV Testing in a Hospital Emergency Department (NCT NCT01258582)
NCT ID: NCT01258582
Last Updated: 2012-06-13
Results Overview
The primary outcome measure was HIV test acceptance rate defined by the proportion of participants whom accepted HIV testing among those randomized within each trial arm (fingerstick or oral fluid).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1651 participants
Primary outcome timeframe
Assess on day subject enrolled into the study
Results posted on
2012-06-13
Participant Flow
The USHER-Phase II study was conducted in the emergency department at Brigham and Women's Hospital, Boston, MA. Between May 5, 2009 and January 4, 2010, USHER-Phase II consented eligible patients for the opportunity to be offered routine opt-in, rapid HIV screening. Enrolled subjects were randomized to fingerstick or oral specimen collection.
Participant milestones
| Measure |
Fingerstick
Fingerstick rapid HIV testing
|
Oral Fluid
Oral fluid rapid HIV testing
|
|---|---|---|
|
Overall Study
STARTED
|
830
|
821
|
|
Overall Study
COMPLETED
|
548
|
563
|
|
Overall Study
NOT COMPLETED
|
282
|
258
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Two Approaches to Routine HIV Testing in a Hospital Emergency Department
Baseline characteristics by cohort
| Measure |
Fingerstick
n=830 Participants
Fingerstick rapid HIV testing
|
Oral Fluid
n=821 Participants
Oral fluid rapid HIV testing
|
Total
n=1651 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
34 years
STANDARD_DEVIATION 13 • n=5 Participants
|
33 years
STANDARD_DEVIATION 13 • n=7 Participants
|
33 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Gender
Female
|
536 participants
n=5 Participants
|
529 participants
n=7 Participants
|
1065 participants
n=5 Participants
|
|
Gender
Male
|
283 participants
n=5 Participants
|
288 participants
n=7 Participants
|
571 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
198 participants
n=5 Participants
|
201 participants
n=7 Participants
|
399 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
188 participants
n=5 Participants
|
200 participants
n=7 Participants
|
388 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
329 participants
n=5 Participants
|
297 participants
n=7 Participants
|
626 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Asain-American
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American/Alaskan Native
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multi-racial/Other
|
85 participants
n=5 Participants
|
92 participants
n=7 Participants
|
177 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Primary Language
English
|
643 participants
n=5 Participants
|
644 participants
n=7 Participants
|
1287 participants
n=5 Participants
|
|
Primary Language
Spanish
|
148 participants
n=5 Participants
|
141 participants
n=7 Participants
|
289 participants
n=5 Participants
|
|
Primary Language
Other
|
34 participants
n=5 Participants
|
29 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
Primary Language
Missing
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Education
Less than High School
|
116 participants
n=5 Participants
|
96 participants
n=7 Participants
|
212 participants
n=5 Participants
|
|
Education
High School/General Education Diploma
|
255 participants
n=5 Participants
|
261 participants
n=7 Participants
|
516 participants
n=5 Participants
|
|
Education
Some College
|
198 participants
n=5 Participants
|
222 participants
n=7 Participants
|
420 participants
n=5 Participants
|
|
Education
College Degree
|
173 participants
n=5 Participants
|
144 participants
n=7 Participants
|
317 participants
n=5 Participants
|
|
Education
Some Post-College/Graduate Degree
|
67 participants
n=5 Participants
|
82 participants
n=7 Participants
|
149 participants
n=5 Participants
|
|
Education
Missing
|
21 participants
n=5 Participants
|
16 participants
n=7 Participants
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assess on day subject enrolled into the studyPopulation: Intent to treat analysis
The primary outcome measure was HIV test acceptance rate defined by the proportion of participants whom accepted HIV testing among those randomized within each trial arm (fingerstick or oral fluid).
Outcome measures
| Measure |
Fingerstick HIV Testing
n=830 Participants
whole-blood fingerstick rapid HIV testing
|
Oral HIV Testing
n=821 Participants
oral fluid rapid HIV testing
|
|---|---|---|
|
Acceptability of the HIV Test
|
0.67 proportion of participants
Interval 0.64 to 0.7
|
0.69 proportion of participants
Interval 0.66 to 0.72
|
Adverse Events
Fingerstick
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Oral Fluid
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fingerstick
n=553 participants at risk
Fingerstick rapid HIV testing
|
Oral Fluid
n=565 participants at risk
Oral fluid rapid HIV testing
|
|---|---|---|
|
Investigations
False-positive rapid test result
|
0.18%
1/553 • Number of events 1
The number at risk only includes subjects who consented to HIV testing after being randomized and offered a rapid HIV test.
|
0.00%
0/565
The number at risk only includes subjects who consented to HIV testing after being randomized and offered a rapid HIV test.
|
|
Investigations
Subject did not follow-up after reactive test
|
0.18%
1/553 • Number of events 1
The number at risk only includes subjects who consented to HIV testing after being randomized and offered a rapid HIV test.
|
0.18%
1/565 • Number of events 1
The number at risk only includes subjects who consented to HIV testing after being randomized and offered a rapid HIV test.
|
Additional Information
Rochelle P. Walensky, MD, MPH
Massachusetts General Hospital
Phone: (617) 724-8445
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place